Clearance Summary
IMAGE received FDA 510(k) clearance under submission number K781169, sponsored by Deringer-Ney, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1978-08-31.
- Submission: K781169
- Applicant / Sponsor: Deringer-Ney, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3060
- Decision date: 1978-08-31
Classification & Regulation
This clearance is catalogued under FDA product code EJT and 21 CFR 872.3060, within the Dental review panel as a Class II device.